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EC number: 277-225-8 | CAS number: 73018-51-6 The complex combination of hydrocarbons obtained by the acid isomerization of linalool. It consists primarily of monoterpenes, terpene alcohols and oxygenated cyclic compounds.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
EYE Irritation:
The BCOP IVIS is 7.45 which is just outside the acceptance for a negative result. However, the QSARs performed on the 4 major components are all negative for eye irritation.
Therefore, no classification is required for eye irritation.
Skin Irritation:
In the in vivo OECD 404 study there is slight irritation observed over 9 days. However, this result alonside the supporting skin irritation observed in the OET test concludes that after a single application Lime Oxide is not irritating to skin and no classification is required.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six days acclimatation.
Unique identification.
Aluminium cages with grid floors.
Environmental max was 21'C and min 20'C and relative humidity was 54%.
A 12h ligh dark cyle.
Standard rabbit diet. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours and 14 days.
- Number of animals:
- 3 male rabbits
- Details on study design:
- 0.5 mL of test material was applied to the intact skin on each rabbit under 2.5 cm x 2.5 cm patches of gauze. The patches were then covered with micopore tape and the trunk was loosly bound with Elastoplast Elastic Bandage with remiained in position for 4 hours. At the end of this period the patches were removed and the skin wiped to remove surplus test material without altering the existing response or the integrity of the epidermis.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: NA
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- probability of weak irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, Lime Oxide Hydrogenated is slightly irritant to rabbit skin.
- Executive summary:
Slighy skin irritation observed, insufficient signs for classification.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1982
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- no guideline available
- Version / remarks:
- Valid method by Klecak,G., Geleick, H., Frey,J.R.
- Principles of method if other than guideline:
- One day before starting induuction procedure, a single application of 0.025 mL of each test concentration (3, 10, 30 and 100%) is simultaneously performed on one of the areas measuring 2 cm of the flank previously clipped and marked with a circular stamp.
- GLP compliance:
- no
- Species:
- guinea pig
- Strain:
- not specified
- Type of coverage:
- open
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Amount / concentration applied:
- 0.025 mL of each test concentration (3, 10, 30 and 100%)
- Duration of treatment / exposure:
- 24 hour
- Observation period:
- 24 hour
- Number of animals:
- 6-8 animals
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mild irritation noted at 100% after a single application at 24 hours.
- Executive summary:
Mild irritation noted at 100% after a single application at 24 hours.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
OECD [Q]SAR Toolbox
2. MODEL (incl. version number)
QSAR Toolbox 3.4.0.17
Database version: 3.8.8/3.1.2
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
CAS: 56058-69-6
SMILES: CC=C(C)C1CCC(C)(C)O1
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
Please see the attached OECD [Q]SAR Toolbox report.
5. APPLICABILITY DOMAIN
The prediction is based on 4 neighbours' values, 3 of them equal to prediction.
Prediction confidence is measured by the p-value = 3.82E-08 (very strong confidence)
6. ADEQUACY OF THE RESULT
Very high confidence in the result as indicated by the p-value.
The single positive result is for Naphtha (petroleum), light catalytic reformed, arom.-free, therefore
considering this substance is a UVCB, this could be impurities or unknown components.
Additionally, the in vivo REACH data for this substance is confirmed as negative and considers data
from 45 studies in the eye irritation summary.
Negative for eye irritation in rabbits. - Endpoint:
- eye irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
OECD [Q]SAR Toolbox
2. MODEL (incl. version number)
QSAR Toolbox 3.4.0.17
Database version: 3.8.8/3.1.2
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
CAS: 586-62-9
SMILES: CC(C)=C1CCC(C)=CC1
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
Please see the attached OECD [Q]SAR Toolbox report.
5. APPLICABILITY DOMAIN
The prediction is based on 5 neighbours' values, 3 of them equal to prediction.
Prediction confidence is measured by the p-value = 9.54E-08 (very strong confidence)
6. ADEQUACY OF THE RESULT
Very high confidence in the result as indicated by the p-value.
Additional:
Negative experimental data on p-mentha-1,4(8)-diene (CAS 586-62-9) has been submitted in the REACH dossier.
Negative for eye irritation in rabbits using predictive QSAR and experimental data. - Endpoint:
- eye irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
OECD [Q]SAR Toolbox
2. MODEL (incl. version number)
QSAR Toolbox 3.4.0.17
Database version: 3.8.8/3.1.2
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
CAS: 99-85-4
SMILES: CC(C)C1CC=C(C)CC=1
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
Please see the attached OECD [Q]SAR Toolbox report.
5. APPLICABILITY DOMAIN
The prediction is based on 13 neighbours' values, 6 of them equal to prediction.
Prediction confidence is measured by the p-value = 1.55E-13 (very strong confidence)
6. ADEQUACY OF THE RESULT
Very high confidence in the result as indicated by the p-value.
The single positive result is for Naphtha (petroleum), light catalytic reformed, arom.-free, therefore
considering this substance is a UVCB, this could be impurities or unknown components.
Additionally, the in vivo REACH data for this substance is confirmed as negative and considers data
from 45 studies in the eye irritation summary.
Negative for eye irritation in rabbits. - Endpoint:
- eye irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
OECD [Q]SAR Toolbox
2. MODEL (incl. version number)
QSAR Toolbox 3.4.0.17
Database version: 3.8.8/3.1.2
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
CAS: 99-86-5
SMILES: CC(C)C1CCC(C)=CC=1
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
Please see the attached OECD [Q]SAR Toolbox report.
5. APPLICABILITY DOMAIN
The prediction is based on 12 neighbours' values, 5 of them equal to prediction.
Prediction confidence is measured by the p-value = 3.37E-11 (very strong confidence)
6. ADEQUACY OF THE RESULT
Very high confidence in the result as indicated by the p-value.
The single positive result is for Naphtha (petroleum), light catalytic reformed, arom.-free, therefore
considering this substance is a UVCB, this could be impurities or unknown components.
Additionally, the in vivo REACH data for this substance is confirmed as negative and considers data
from 45 studies in the eye irritation summary.
Negative for eye irritation in rabbits. - Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- The test article, a colourless to pale yellow liquid, was identified as Lime Oxide.
A certificate of analysis for the test article was provided.
The test article was administered without dilution. - Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Corneas were obtained from bovine eyes supplied by a local abattoir. The eyes were
removed after slaughter, completely immersed in Hanks’ Balanced Salt Solution
(containing penicillin at 100 IU/mL and streptomycin at 100 μg/mL) in a suitably
sized container and transported on the same day to the testing facility.
On arrival at the test facility the eyes were carefully examined for defects including
increased opacity, scratches and neovascularisation. Only corneas free from such
defects were used.
Fresh corneas, mounted onto specifically designed holders were treated topically with
the test material. Eye corrosion / severe irritation potential was based on the combined
effect of the test article on the opacity of the cornea following the treatment and the
cornea’s ability to resist penetration of a fluorescent dye through the tissue. - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 750 μL
- Duration of treatment / exposure:
- 10 minute incubation at 32°C ± 1°C.
- Observation period (in vivo):
- NA
- Duration of post- treatment incubation (in vitro):
- NA
- Number of animals or in vitro replicates:
- three corneas
- Details on study design:
- A volume of 750 μL of the test article was applied to each of three corneas followed
by a ten minute incubation at 32°C. After this incubation, each cornea was washed
with media containing phenol red (as a pH indicator) until this indicator showed no
pH effect occurring (and demonstrating that the test article had been removed
successfully). The corneas were then washed once in media without phenol red. The
corneas were incubated (horizontally) for 2 hours ± 10 minutes after which corneal
opacity was measured.
For the permeability endpoint, the media in the anterior chamber was replaced with
1 mL of sodium fluorescein (4 mg/mL solution), while the posterior chamber was
filled with fresh MEM. The corneas were incubated in the vertical position for
90 minutes. Following this period, the media in the posterior chamber was removed
and held in a labelled tube. Three 350 μL aliquots of this media (per cornea) were
analysed for optical density at 490 nanometers (OD490) using a spectrophotometer.
A volume of 750 μL of the negative or positive control was similarly applied to
further groups of three corneas. These groups were subject to the procedures detailed
above. - Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 4.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- Corneal Opacity:
The mean corrected opacity reading for the test article was 4.7.
The mean corrected opacity reading for the negative control was 0.0.
The mean corrected opacity reading for the positive control was 39.3.
The corneas treated with the positive control were noted to be cloudy following treatment.
Corneal Permeability:
The mean group corrected optical density for the test article was 0.185.
The mean group corrected optical density for the negative control was 0.0.
The mean group corrected optical density for the positive control was 0.203. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test article, Lime Oxide, produced an IVIS score of 7.45. No prediction can be made in respect of its potential to cause eye irritation.
The assay was considered valid as the assay acceptance criteria were met. - Executive summary:
The test article, Lime Oxide, produced an IVIS score of 7.45.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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